Reconstitution diluting

Additives maybe incompatible with the reconstituted (diluted) solution required for IV infusion... 

Fluosol Green Cross Corp. (Japan) FDC/FTPA 7 3 6/7 11% (20%) Pluronic F68 EYP K oleate Frozen stem emulsion Reconstitute dilute Approved in the U.S. for PTCA 1989. Discontinued... 

ITRACONAZOLE Give the drug orally with food to increase absorption. When administering IV, use only components provided by the manufacturer for reconstitution. Do not dilute with any other diluent. The drug... 

The palytoxin used was obtained from Moore and Scheuer, University of Hawaii. The crude toxin was purified and analyzed by Sephadex columns, reconstituted in 50% ethanol and water, stored in a refrigerator, and bioassayed for potency at least once a week during use. All dilutions of the palytoxin were made with glass distilled water. 

Reconstitute the dry plant residue from Section 6.2.1 in 50 mL of hexane saturated with acetonitrile and transfer the flask contents to a 250-mL separatory funnel. Rinse the round-bottom flask with 50 mL of acetonitrile saturated with hexane and add this rinse to the hexane in the separatory funnel. Partition the residue from the hexane into the acetonitrile. Drain the acetonitrile into the 500-mL flask from the dichloromethane partition step (Section 6.2.1). Re-extract the remaining hexane phase with an additional 50 mL of acetonitrile saturated with hexane. Combine the acetonitrile fraction with the acetonitrile from the first partition. Concentrate the combined acetonitrile fractions to dryness in a rotary evaporator at <40 °C. Dissolve the dry residue in 1 mL of ethyl acetate and dilute the sample with 2mL of hexane. Sonicate the sample for... 

The choice of the excipients and their concentration, including their function (e.g., antimicrobial preservatives, antioxidants. ..). In the case of antimicrobial preservatives, data are expected on the preservative efficacy in products on storage, including after reconstitution or dilution and during the period of use. 

For parenteral products specific consideration needs to be included for tonicity adjustment, emulsion globule size, ease of resuspension and sedimentation rate, particle size and particle size distribution, viscosity and syringeability, and crystal form changes. Full consideration should be included of the proposed instructions for dilution or reconstitution of products and of compatibility with the proposed solvents or diluents. This should include a demonstration that the proposed storage temperature and extremes of concentration are suitable. 

The purpose of in-use stability studies is to establish the period for which a product intended to be used on more than one occasion may be used after reconstitution or dilution or the withdrawal of the first dose from the container without adversely affecting the integrity of the product and with the product retaining acceptable quality characteristics. This type of test can be applied to any multiple use product (e.g., sterile products in multiple-use containers, powders or granules including those used to produce oral solutions or suspensions) but is likely to be of particular importance in the case of products that are manufactured with an inert headspace gas, for products containing antioxidants to protect an active ingredient that is liable to oxidative decomposition, and for products that contain a volatile antimicrobial preservative. 

The application should state the rationale for the design of the in-use stability tests performed. The procedures used should be fully validated. One key factor is that the test should simulate the use of the product as far as practicable. This should include any reconstitution or dilution prior to use. Aliquots should be removed in an appropriate manner following, as far as possible, the usage pattern that will be encountered in practice. Physical (color, clarity, closure integrity, particulate matter, and particulates/particle size), chemical (assays for active ingredient, antioxidants and... 

In a typical extraction, 50 jiL of plasma was treated with 25 /./I. of internal standard solution and then diluted with 200 /iL of 3% ammonium hydroxide. The C18 /./-SPE tips were conditioned with 150 /iL of methanol and then 300 /./I. of 3% ammonium hydroxide. The sample was exhaustively extracted by aspirating and dispensing the plasma samples seven times from the dilution tube. For the wash, 90 /./I. of 3% ammonium hydroxide followed by 100 /./I. of methanokwater (20 80 v/v) was used. Elution was achieved with 50 /./I. of methanokwater (90 10 v/v). After evaporation of the collected eluate in the 96-well block, the residues were reconstituted in 200 fjL of mobile phase A B... 

Direct injection of plasma or supernatant after protein precipitation on a short column with a high liquid flow rate is a common method for reducing analysis time in the pharmaceutical industry. The direct injection of a sample matrix is also known as the dilute-and-shoot (DAS) approach.62 DAS can be applied to all types of matrices and approaches and is the simplest sample preparation method with matrix dependency. Direct injection can also be approached through the extraction of eluent from PPT, SPE, and LLE onto a normal phase analytical column. The procedure is called hydrophilic interaction liquid chromatography (HILIC)70110111 and it avoids the evaporation and reconstitution steps that may cause loss of samples from heat degradation and absorption. 

Mounting mount sections in aqueous medium or balsam for brightfield microscopy or in antifade medium for fluorescence microscopy (see Sect. 3.2.2). Notes. A11 incubations are at room temperature unless otherwise noted. Nuclear dyes (DAPI, Hoechst 33342 and Propidium Iodide) supplied as lyophilized solids are usually reconstituted in methanol. The stock solutions (5 mg/ml) are stable for many years when stored frozen at < 20°C and protected from light. Before use, the stock solution is further diluted in PBS to the final concentration of 5 pg/ml. 

If the analyte is too dilute for the chosen method, its concentration may be increased in any number of ways. One is a controlled evaporation of the solvent (such that the factor by which its concentration is increased is known). Another is to perform an extraction that results in a smaller solution volume for the same quantity of analyte. Another is to evaporate the analyte solution to dryness and then reconstitute (i.e., redissolve) with a smaller volume of solvent. 

Figure 1 Continued on next page) Immunopotentiating reconstituted influenza virosomes (IRIV) induced antigen specific proliferation of CD4+CD45RO+ cells. (A) Peripheral blood mononuclear cells (PBMQ from healthy donors n=3) were cultured in the absence of stimuli (Neg), in the presence of IRIV (V), and in the presence of control liposomes (L) at the indicated dilutions. Proliferation was measured on day 6 of culture by H-thymidine incorporation. (B) Cord blood mononuclear cells from two donors were cultured in the absence of stimuli (Neg) or in the presence of phytohaemag-glutinin (PHA), concanavalin A (ConA), IRIV (V) or L at the indicated concentrations. Proliferation was measured on day 3 of culture for PHA and ConA cultures and on day 6 for IRIV and L stimulated cultures. (Q Purified CD4+ or CD8+ cells were cocultured with autologous irradiated PBMC in the absence of stimuli (Neg) and in the presence of IRIV (V) at the indicated concentrations. Proliferation was measured on day 6 of culture by H-thymidine incorporation. (D) Purified CD4/CD45RA+ cells and CD4/CD45RO-I-cells were isolated from PBMC of one healthy donor and cocultured with autologous irradiated PBMC in the presence of IRIV (V) or L at the indicated concentration. Proliferation was measured on day 6 of culture by H-thymidine incorporation. Source From Ref 6.

Figure 3 Cytokine secretion in immunopotentiating reconstituted influenza viro-somes (IRIV)-stimulated peripheral blood mononuclear cells (PBMC). PBMC from a healthy donor were cultured in the absence of stimuli (Neg) or in the presence of IRIV (V, 1 50 diluted) or control liposomes (L, 1 50 diluted). On days 1, 2, and 4 supernatants were harvested and the concentrations of interferon-y (A), GM-CSF (B), TNF-a (C), and interleukin-4 (D) were determined by ELISA. Abbreviations GM-CSF, granulocyte monocyte colony stimulating factor TNF-a, tumor necrosis factor-a. Source From Ref. 6.

Figure 4 Increased percentages of CXCR3+CD4+ T cells in immunopotentiating reconstituted influenza virosomes (IRIV) stimulated peripheral blood mononuclear cells (PBMC). Healthy donors PBMC were cultured in the absence of stimuli (A), in the presence of liposomes [1 50 flnal dilution, (B)], or IRIV [1 50 final dilution, (C)]. After six days, culture cells were phenotyped for the expression of CXCR3 and CD4 by phosphatidylethanolamine and fluorescein isothiocyanate labelled monoclonal antibodies respectively. Source. From Ref 6.

Fig. 3. Gallery of representative nucleosomes reconstituted in the absence (a) or presence of GH5 (b) or H5 (c), and visualized by scanning transmission electron microscopy, (a) and (b) 256 bp 5S rDNA fragment [65]. (c) 357 bp fragment from the 5S series (see text). Samples were diluted in TE buffer supplemented with 50 mM NaCl and 5 mM MgCl2 before adsorption to the grids. Note the nucleosome different positions relative to the DNA ends. Bars 25 nm and 75 bp. (Adapted from Fig. 7,9, and 10 in Ref [34].) Schemes of the corresponding DNA conformations are shown.

The self-assembly of this fundamental building block of chromatin is a topic of enduring interest. DNase I digestion experiments as well as spectroscopic studies indicate that nucleosome core particles can be reconstituted by salt-jump (i.e., diluting NaCl concentration from 2.0 to 0.2 M) or by direct mixing of histones and DNA at the lower salt concentration. Daban and Cantor used the increase in eximer fluorescence to investigate the reassembly process in terms of a two-state model ... 

IV infusion (20 or 40 mg) over 10 to 30 minutes A solution for IV infusion is prepared by first reconstituting the contents of 1 vial with 5 ml of 0.9% sodium chloride injection, lactated Ringer s injection, or 5% dextrose injection, and further diluting the resulting solution to a final volume of 50 ml. The solution (admixture) should be administered as an IV infusion over a period of 10 to 30 minutes. 

Administer by slow IV drip infusion only, either as continuous or intermittent infusion. Do not use equipment containing aluminum (eg, needles, cannulae). If used with a primary IV fluid system, discontinue the primary solution during infusion. Do not give by direct IV bolus injection because of the low pH (0.5 to 2) of the reconstituted product. The drug must be further diluted and neutralized for infusion. Do not introduce additives into the solution. 

IV administration Voriconazole IV for injection requires reconstitution to 10 mg/mL and subsequent dilution to 5 mg/mL or less prior to administration as an infusion. 

IV For IV infusion, further dilute reconstituted capreomycin solution in 100 mL of 0.9% Sodium Chloride Injection and administer over 60 minutes. 

Phlebitis/Pain at injection site Initially, reconstituted ganciclovir solutions have a high pH (pH 11). Despite further dilution in IV fluids, phlebitis or pain may occur at the site of IV infusion. Take care to infuse solutions containing ganciclovir only into veins with adequate blood flow to permit rapid dilution and distribution. 

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